Reprocessing of single-use medical devices in the EU
Before we start dealing with the topic of reusing single-use medical devices (so-called reprocessing), we should first clarify what it is about, what consequences it can have for patients and under what circumstances it is or may be possible.
According to the European Union Medical Device Regulation (“MDR”), which will come into force in May 2020, reprocessing means a process which includes many (approx. 19) activities, including cleaning, disinfection, sterilisation, labelling, packaging, transport, and placing on the market of a used device in order to allow safe reuse of a single-use medical device, if certain conditions defined in the MDR are met.
Example: A patient who is to undergo a total endoprosthesis will receive a used knee joint replacement instead of a new one. The used knee joint should meet the same safety and performance criteria as a new device. The problem is that the MDR does not define these safety specifications/criteria ‒ indeed, they are currently not specified at all.
Patients should be aware that, according to the MDR, EU member states can choose whether to introduce reprocessing and, if so, under what conditions.
In Slovakia, the Czech Republic, Poland, the Baltic states or Hungary, reprocessing of single-use medical devices is prohibited. In general, if a patient is infected or dies as a result of illegal use of a reprocessed medical device, this could be a criminal offence. In Germany, reprocessing of medical devices has been permitted since 2001, so that no distinction is made between single-use medical devices and multiple-use medical devices. Instead, medical devices are divided into different risk categories for which different safety criteria apply. In Germany, reprocessing is regulated by federal regulations and ordinances which refer to the recommendations of the Robert Koch Institute (“RKI”) and the Federal Institute for Drugs and Medical Devices The reprocessing requirements laid down in the recommendations of the RKI must be complied with. For reprocessing of medical devices, which are placed in risk category “C”, the quality management system of the reprocessor has to be certified. In Germany, this accreditation is granted by the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (EN: Central Office of the States for the Health Protection of Medicinal Products and Medical Devices).
Regarding the reprocessing of single-use medical devices in Slovakia, in October 2019 the Parliament did not adopt an amendment to the Act on Drugs and Medical Devices as proposed by the Ministry of Health of the Slovak Republic. Following major criticism, in particular from the Association of Medical Device Suppliers (SK+ MED), provisions introducing reprocessing of single-use medical devices were omitted from the draft.
The Ministry of Health responded to criticism from the Association of Medical Device Suppliers by stating that reprocessed medical devices may be used in Slovakia, and that the draft Act on Drugs and Medical Devices is in line with the MDR. The Ministry stated that the draft aimed to specify that used medical devices may be used only if they have been reprocessed. These medical devices should meet the same quality and safety requirements as the original medical devices.
Why is this topic controversial for the general public, but also for lawyers concerned with medical law, and last but not least, for medical device suppliers?
The draft law on drugs and medical devices referred to the MDR when regulating the reprocessing of medical devices. Neither the MDR, nor the already-prepared Commission Implementing Regulation, as we note below, clearly defines what these “same” quality and safety requirements are and how they are determined.
At a time when no common specifications for patient safety have yet been set in the EU, reprocessing of medical devices also raises fears that the standard of reprocessing will not be the same in every EU country. Proposals and comments on the Commission Implementing Regulation “Single-use medical devices - safety and performance requirements on reprocessing”, which were raised by 20 subjects during public discussion in the summer of 2019, are currently being evaluated. Several participants in this discussion from Ireland, Germany, as well as from the USA, in particular the organisation MedTech Europe, have raised objections against the common specifications because they allegedly regulate something that is not regulated in the MDR, or that go beyond the scope of the MDR (e.g. they doubly regulate the duties of the reprocessor, which has the position of the manufacturer of the medical device), and due to a lack of concrete definitions and specifications where these are explicitly desirable. Another criticism is that before the reprocessing of a medical device the healthcare facility (e.g. hospital) has to carry out a preliminary examination to establish whether the medical device is suitable for reprocessing, and for this purpose the documentation of the manufacturer, the design know-how, the construction characteristics, the characteristics of the material, and so on, must be checked. The practical situation is not solved if the manufacturer refuses to provide the information mentioned (which is highly probable) so that reprocessing on the part of hospitals becomes de facto impossible.
From the patients’ point of view, if we use the abovementioned illustrative example of a knee joint replacement, the question arises as to whether fears with regard to the free movement of goods are justified, due to the absence of common specifications and a control standard that is not uniform in the EU at present, and whether an artificial kneecap reprocessed in Hungary, where the quality management system (“QMS”) does not have to be certified by a notified body (although this is also not required under the MDR), will have the same quality as a kneecap reprocessed in Germany, where the QMS is subject to certification.
We are of the opinion that, in the current legal situation, non-implementation of the reprocessing of single-use medical devices was the right decision. The Commission Implementing Regulation is in the approval process, and it is not yet clear whether the Commission will take into account justified and essential objections regarding common specifications raised by the expert public.